Actively Recruiting
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
Led by Alpha Tau Medical LTD. · Updated on 2025-12-08
15
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
CONDITIONS
Official Title
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically proven NCCN locally advanced pancreatic cancer
- Patients must have received at least one line of chemotherapy or be medically unfit for further chemotherapy
- Tumor is not resectable with radical surgery or patient refuses surgery
- DaRT indication validated by a multidisciplinary team
- Measurable lesion per RECIST (version 1.1) criteria
- Treatment at Verona's center within the past month
- Lesion size 5 cm or less in longest diameter
- Age 18 years or older
- ECOG Performance Status Scale 2 or less
- Life expectancy more than 6 months
- White blood cell count at least 3500/µl, granulocytes at least 1500/µl
- Platelet count at least 60,000/µl
- Creatinine clearance at least 30 cc/min or at least 40 cc/min with stable creatinine levels
- AST and ALT levels 2.5 times or less the upper limit of normal
- INR below 1.4 for patients not on Warfarin
- Willing and able to sign informed consent
- Women of childbearing potential must have a negative pregnancy test before implantation and use contraception for 3 months after treatment
- Agreement to use adequate contraception before, during, and for 3 months after study participation
You will not qualify if you...
- Chemotherapy or immunotherapy within 4 weeks prior to study
- Prior radiation therapy to the pancreas
- CA 19-9 level greater than 1000 Units/ml
- Fit for surgical exploration unless refusing surgery
- Known allergy to treatment components
- Systemic immunosuppressive therapy except brief corticosteroid use
- Significant cardiovascular disease (e.g., severe heart failure, uncontrolled heart conditions, recent heart attack)
- Uncontrolled illnesses including active infections requiring systemic therapy (except cholangitis), psychiatric or substance abuse disorders interfering with study
- Known progressing additional malignancy requiring active treatment (exceptions apply)
- Need for treatments not specified in the protocol that might affect study outcomes
- Refusal or inability to use adequate contraception as required
- Participation in another interventional study in past 30 days that conflicts with this study
- High risk of not following the study protocol
- Breastfeeding women or women unwilling to use contraception as required
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chirurgia Generale e del Pancreas, Istituto del Pancreas
Verona, Italy
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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